FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

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Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

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Papal Conclave Accompanied by Reports of Scandals and Intrigue

Osservatore Romano/Reuters

Pope Benedict XVI, right, spoke to cardinals at the Vatican on Saturday.

VATICAN CITY — As cardinals from around the world begin arriving in Rome for a conclave to elect a successor to Pope Benedict XVI, new shadows have fallen over the delicate transition, which the Vatican fears might influence the vote and with it the direction of the Roman Catholic Church.

In recent days, often speculative reports in the Italian news media — some even alleging gay sex scandals in the Vatican, others focusing on particular cardinals stung by the child sex abuse crisis — have dominated headlines, suggesting fierce internal struggles as prelates scramble to consolidate power and attack enemies in the dying days of a troubled papacy.

The reports, which the Vatican has vehemently denied, touch on some of the most vexing issues of Benedict’s reign, including the child sex abuse crisis and international criticisms of the Vatican Bank’s opaque record-keeping. The recent explosion of bad press — which some Vatican experts say is fed by carefully orchestrated leaks meant to weaken some papal contenders — also speak to Benedict’s own difficulties governing, which analysts say he is trying to address, albeit belatedly, with several high-profile personnel changes.

The drumbeat of scandal has reached such a fever pitch that on Saturday, the Vatican Secretariat of State issued a rare pointed rebuke, calling it “deplorable” that ahead of the conclave there was “a widespread distribution of often unverified, unverifiable or completely false news stories, that cause serious damage to persons and institutions.”

The Vatican compared the news reports to past attempts by foreign states to exert pressure on the papal election, saying the latest efforts to skew the choice of the next pope by trying to shape public opinion were “based on judgments that do not typically capture the spiritual aspect of the moment that the Church is living.”

Benedict had hoped to address at least one scandal with the Feb. 15 appointment of a new head of the Vatican Bank. It is less clear why he reassigned a powerful Vatican diplomatic official to a posting outside Rome, though experts say it diminishes the official’s role in helping steer Vatican policy.

On Feb. 11, Benedict made history by announcing that he would step down by month’s end. He said he was worn down by age and was resigning “in full liberty and for the good of the Church.” The volley of news reports since appeared to underscore the backbiting in the Vatican that Benedict was unable to control, and provided a hint of why he might have decided that someone younger and stronger should lead the church.

At the conclusion of the Vatican’s Lenten spiritual retreat, Cardinal Gianfranco Ravasi, the director of the Pontifical Council for Culture and a papal contender, spoke darkly of the “divisions, dissent, careerism, jealousies” that he said plagued the Vatican hierarchy.

The recent spate of news reports were linked to an earlier scandal in which the pope’s butler stole confidential documents that was considered one of the gravest security breaches in the modern history of the church.

Last week, largely unsourced articles in the center-left daily La Repubblica and the center-right weekly Panorama reported that three cardinals whom Benedict had asked last summer to investigate the leaking of the documents, known as the “VatiLeaks” scandal, had found evidence of Vatican officials who had been put in compromising positions.

The newspapers reported that, after interviewing dozens of people inside and outside the Vatican, the cardinals produced a hefty dossier. “The report is explicit. Some high prelates are subject to ‘external influence’ — we would call it blackmail — by nonchurch men to whom they are bound by ‘worldly’ ties,” La Repubblica wrote.

Vatican experts speculated that prelates eager to undermine opponents during the conclave were behind the leaks to the news media over the last week.

“The conclave is a mechanism that serves to create a dynasty in a monarchy without children, so it’s a complicated operation,” said Alberto Melloni, the director of the John XXIII Center in Bologna and the author of a book on conclaves.

This article has been revised to reflect the following correction:

Correction: February 23, 2013

An earlier version of this article misspelled the last name of a cardinal. His name is Roger M. Mahony, not Roger M. Mahoney.

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From Homeless in the Congo to the Oscars Red Carpet: The Story You Must Read Before Tomorrow

Stylewatch
Style News Now

02/23/2013 at 05:40 PM ET

Courtesy Rachel Mwanza

One of the best stories from this year’s Oscars ceremony isn’t taking place on screen, but rather on the red carpet.

Rachel Mwanza, the 16-year-old star of the Best Foreign Language Film nominee War Witch, will be joining her fellow nominees in L.A. after obtaining a visa from the war-torn Democratic Republic of the Congo just days before the Oscars.

The young actress was “discovered” by the War Witch team from a documentary called Kinshasa Kids, which portrayed the life of Mwanza and other children living on the streets in the Congo.

Since being cast in the film, in which she plays a child kidnapped and enslaved to a life of guerilla warfare, her life has changed dramatically — from having a home and education paid for to winning a best actress award at the Berlin Film Festival.

And since her flight arrived late Friday night, she needed a red carpet-worthy dress quickly, which is where Rent the Runway stepped in.

The designer rental service rushed Mwanza several dresses to wear to the Independent Spirit Awards Saturday, from which she chose Kate Spade New York’s “Tiebreaker” style, adding Chamak by Priya Kakkar bangles and a Judith Leiber clutch.

“I’m so excited to be in Los Angeles. I’ve never seen the ocean before!” Mwanza tells PEOPLE through a translator. “I’m tired from my long trip, but way too excited to rest!”

She shared exclusive shots with PEOPLE (above) of her trying-on process, including shots of her caretaker “Mama” helping her zip into her final dress, and the many jewels she was sent to choose from.

And it didn’t take much to get Mwanza ready for her high-profile debut: “I’m going to work it on the red carpet,” she says. “I’ve been practicing my poses!”

The one disappointment from her trip so far? No sightings of a certain superstar. “Beyoncé is my favorite in the whole world. Why is she not here?!” Mwanza jokes.

Below, see a shot of Mwanza and her War Witch producers Marie-Claude Poulin and Pierre Even at the Independent Spirit Awards, and be sure to watch her film, which will be On Demand beginning Tuesday and in select theaters March 1.

And keep an eye out for her at the Oscars Sunday night, where she’ll be wearing a top-secret dress made for her by an African designer. Can’t wait to see her poses!

Courtesy Rachel Mwanza

–Alex Apatoff

PHOTOS: SEE MORE OSCARS STYLE HERE!

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FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

Read More..

Investors face another Washington deadline

NEW YORK (Reuters) - Investors face another Washington-imposed deadline on government spending cuts next week, but it's not generating the same level of fear as two months ago when the "fiscal cliff" loomed large.

Investors in sectors most likely to be affected by the cuts, like defense, seem untroubled that the budget talks could send stocks tumbling.

Talks on the U.S. budget crisis began again this week leading up to the March 1 deadline for the so-called sequestration when $85 billion in automatic federal spending cuts are scheduled to take effect.

"It's at this point a political hot button in Washington but a very low level investor concern," said Fred Dickson, chief market strategist at D.A. Davidson & Co. in Lake Oswego, Oregon. The fight pits President Barack Obama and fellow Democrats against congressional Republicans.

Stocks rallied in early January after a compromise temporarily avoided the fiscal cliff, and the Standard & Poor's 500 index <.spx> has risen 6.3 percent since the start of the year.

But the benchmark index lost steam this week, posting its first week of losses since the start of the year. Minutes on Wednesday from the last Federal Reserve meeting, which suggested the central bank may slow or stop its stimulus policy sooner than expected, provided the catalyst.

National elections in Italy on Sunday and Monday could also add to investor concern. Most investors expect a government headed by Pier Luigi Bersani to win and continue with reforms to tackle Italy's debt problems. However, a resurgence by former leader Silvio Berlusconi has raised doubts.

"Europe has been in the last six months less of a topic for the stock market, but the problems haven't gone away. This may bring back investor attention to that," said Kim Forrest, senior equity research analyst at Fort Pitt Capital Group in Pittsburgh.

OPTIONS BULLS TARGET GAINS

The spending cuts, if they go ahead, could hit the defense industry particularly hard.

Yet in the options market, bulls were targeting gains in Lockheed Martin Corp , the Pentagon's biggest supplier.

Calls on the stock far outpaced puts, suggesting that many investors anticipate the stock to move higher. Overall options volume on the stock was 2.8 times the daily average with 17,000 calls and 3,360 puts traded, according to options analytics firm Trade Alert.

"The upside call buying in Lockheed solidifies the idea that option investors are not pricing in a lot of downside risk in most defense stocks from the likely impact of sequestration," said Jared Woodard, a founder of research and advisory firm condoroptions.com in Forest, Virginia.

The stock ended up 0.6 percent at $88.12 on Friday.

If lawmakers fail to reach an agreement on reducing the U.S. budget deficit in the next few days, a sequester would include significant cuts in defense spending. Companies such as General Dynamics Corp and Smith & Wesson Holding Corp could be affected.

General Dynamics Corp shares rose 1.2 percent to $67.32 and Smith & Wesson added 4.6 percent to $9.18 on Friday.

EYES ON GDP DATA, APPLE

The latest data on fourth-quarter U.S. gross domestic product is expected on Thursday, and some analysts predict an upward revision following trade data that showed America's deficit shrank in December to its narrowest in nearly three years.

U.S. GDP unexpectedly contracted in the fourth quarter, according to an earlier government estimate, but analysts said there was no reason for panic, given that consumer spending and business investment picked up.

Investors will be looking for any hints of changes in the Fed's policy of monetary easing when Fed Chairman Ben Bernake speaks before congressional committees on Tuesday and Wednesday.

Shares of Apple will be watched closely next week when the company's annual stockholders' meeting is held.

On Friday, a U.S. judge handed outspoken hedge fund manager David Einhorn a victory in his battle with the iPhone maker, blocking the company from moving forward with a shareholder vote on a controversial proposal to limit the company's ability to issue preferred stock.

(Additional reporting by Doris Frankel; Editing by Kenneth Barry)

Read More..

In Niger, U.S. Troops Set Up Drone Base

WASHINGTON — Opening a new front in the drone wars against Al Qaeda and its affiliates, President Obama announced on Friday that about 100 American troops had been sent to Niger in West Africa to help set up a new base from which unarmed Predator aircraft would conduct surveillance in the region.

The new drone base, located for now in the capital, Niamey, is an indication of the priority Africa has become in American antiterrorism efforts. The United States military has a limited presence in Africa, with only one permanent base, in Djibouti, more than 3,000 miles from Mali, where insurgents had taken over half the country until repelled by a French-led force.

In a letter to Congress, Mr. Obama said about 40 United States military service members arrived in Niger on Wednesday, bringing the total number of those deployed in the country to about 100 people. A military official said the troops were largely Air Force logistics specialists, intelligence analysts and security officers.

Mr. Obama said the troops, who are armed for self-protection, would support the French-led operation that last month drove the Qaeda and affiliated fighters out of a desert refuge the size of Texas in neighboring Mali.

Niger, one of the poorest countries in the world, signed a status-of-forces agreement last month with the United States that has cleared the way for greater American military involvement in the country and provides legal protection to American troops there.

In an interview last month in Niamey, President Mahamadou Issoufou voiced concern about the spillover of violence and refugees from Mali, as well as growing threats from Boko Haram, an Islamist extremist group to the south, in neighboring Nigeria.

French and African troops have retaken Mali’s northern cities, including Timbuktu, Gao and Kidal, but about 2,000 militants have melted back into desert and mountain hideaways and have begun a small campaign of harassment and terror, dispatching suicide bombers, attacking guard posts, infiltrating liberated cities or ordering attacks by militants hidden among civilians.

“Africa Command has positioned unarmed remotely piloted aircraft in Niger to support a range of regional security missions and engagements with partner nations,” Benjamin Benson, a command spokesman in Stuttgart, Germany, said in an e-mail message on Friday.

Mr. Benson did not say how many aircraft or troops ultimately would be deployed, but other American officials have said the base could eventually have as many as 300 United States military service members and contractors.

For now, American officials said Predator drones would at first fly only unarmed surveillance drones, although they have not ruled out conducting missile strikes at some point if the threat worsens.

American officials would like to move the aircraft eventually to Agadez, a city in northern Niger that is closer to parts of northern Mali where cells of Al Qaeda in the Islamic Maghreb and other militants groups are operating. Gen. Carter F. Ham, the leader of the Pentagon’s Africa Command, visited the base last month as part of discussions with Niger’s leaders on closer counterterrorism cooperation.

The new drone base will join a constellation of small airstrips in recent years on the continent, including one in Ethiopia, for surveillance missions flown by drones or turboprop planes designed to look like civilian aircraft.

A handful of unarmed Predator drones will fill a desperate need for more detailed information on regional threats, including the militants in Mali and the unabated flow of fighters and weapons from Libya. General Ham and intelligence analysts have complained that such information has been sorely lacking.

As the United States increased its presence in Niger, Russia sent a planeload of food, blankets and other aid to Mali on Friday, a day after Foreign Minister Sergey V. Lavrov warned about the spread of terrorism in North Africa, which the Russian government has linked to Western intervention in Libya.

Mr. Lavrov met on Thursday with the United Nations special envoy for the region, Romano Prodi, to discuss the situation in Mali, where Russia has supported the French-led effort to oust Islamist militants. But Russia has also blamed the West for the unrest and singled out the French in particular for arming the rebels who ousted the Libyan leader, Col. Muammar el-Qaddafi.

“Particular concern was expressed about the activity of terrorist organizations in the north, a threat to regional peace and security,” the Russian Foreign Ministry said in a statement after the meeting. “The parties agreed that the uncontrolled proliferation of arms in the region in the wake of the conflict in Libya sets the stage for an escalation of tension throughout the Sahel.” The Sahel is a vast region stretching more than 3,000 miles across Africa, from the Atlantic in the west through Sudan in the east.

In a television interview this month, Mr. Lavrov said, “France is fighting against those in Mali whom it had once armed in Libya against Qaddafi.”

Eric Schmitt reported from Washington, and Scott Sayare from Paris. David M. Herszenhorn contributed reporting from Moscow.

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The Hunger Games: Katniss & Peeta's Victory Tour Look Revealed

02/22/2013 at 06:00 PM EST

They survived the Hunger Games – but will they survive the Victory Tour?

Sporting bridal-like attire, Katniss (Jennifer Lawrence) and Peeta (Josh Hutcherson) pose for a promotional poster for the Victory Tour – which – in the Hunger Games universe – is when the victor of the annual Hunger Games tournament visits each of the fictional Panem's districts.

As true Hunger Games fans know, there is usually only one victor – but Katniss and Peeta rebelled against the Capitol in the first movie, originally opting for joint suicide instead of murder.

The softer look is a deliberate statement, meant to continue the charade that Katniss and Peeta were blinded by love when they rebelled against the rules in the arena.

The second film, Catching Fire, hits theaters Nov. 22.

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FDA approves new targeted breast cancer drug

WASHINGTON (AP) — The Food and Drug Administration has approved a first-of-a-kind breast cancer medication that targets tumor cells while sparing healthy ones.

The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.

Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.

"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."

Cobleigh helped conduct the key studies of the drug at the Chicago facility.

The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2. Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.

The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast cancer marketplace. The drug had sales of roughly $6 billion last year.

Genentech said Friday that Kadcyla will cost $9,800 per month, compared to $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.

FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.

Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

FDA specifically approved the drug for patients with advanced breast cancer who have already been treated with Herceptin and taxane, a widely used chemotherapy drug. Doctors are not required to follow FDA prescribing guidelines, and cancer researchers say the drug could have great potential in patients with earlier forms of breast cancer

Kadcyla will carry a boxed warning, the most severe type, alerting doctors and patients that the drug can cause liver toxicity, heart problems and potentially death. The drug can also cause severe birth defects and should not be used by pregnant women.

Kadcyla was developed by South San Francisco-based Genentech using drug-binding technology licensed from Waltham, Mass.-based ImmunoGen. The company developed the chemical that keeps the drug cocktail together and is scheduled to receive a $10.5 million payment from Genentech on the FDA decision. The company will also receive additional royalties on the drug's sales.

Shares of ImmunoGen Inc. rose 2 cents to $14.32 in afternoon trading. The stock has ttraded in a 52-wek range of $10.85 to $18.10.

Read More..

15 G.O.P. Senators Ask Obama to Withdraw Hagel Nomination

WASHINGTON — A group of 15 Republican senators insisted on Thursday that President Obama withdraw the nomination of Chuck Hagel to be defense secretary, the latest move in a contentious battle to block the confirmation of their former colleague.

But even as Republican senators tried to throw up another obstacle, Senate Democrats said they were pushing ahead with plans to hold a final up-or-down vote on the nomination no later than Wednesday.

Should that vote proceed as planned, Mr. Hagel’s confirmation appears assured. Several Republicans have said that they intend to drop their attempts to filibuster the nomination.

But given how deeply divided Mr. Hagel’s nomination has left the Senate, the outlook in the immediate term is murky.

Many Republicans, like the 15 who wrote to the president on Thursday, signaled that they would not let the issue die quietly. And those who have said that they would ultimately not support a filibuster, like Deb Fischer of Nebraska and Richard Shelby of Alabama, were choosing their words carefully.

Saying that Mr. Hagel’s confirmation would be “unprecedented” because of near-unanimous opposition from Republicans, the group of 15 senators urged Mr. Obama to pick another candidate.

“Over the last half-century, no secretary of defense has been confirmed and taken office with more than three senators voting against him,” they wrote. “The occupant of this critical office should be someone whose candidacy is neither controversial or divisive.”

Signing the letter were John Cornyn of Texas, the No. 2 Senate Republican; Lindsey Graham and Tim Scott of South Carolina; Roger Wicker of Mississippi; David Vitter of Louisiana; Ted Cruz of Texas; Mike Lee of Utah; Patrick J. Toomey of Pennsylvania; Marco Rubio of Florida; Dan Coats of Indiana; Ron Johnson of Wisconsin; James E. Risch of Idaho; John Barrasso of Wyoming; and Tom Coburn and James Inhofe of Oklahoma.

Members of the group cited a litany of objections, including Mr. Hagel’s unimpressive showing at his confirmation hearing, which drew criticism from members of both parties, and what they said was his “dangerous” posture toward dealing with Iran.

The level of derision directed at Mr. Hagel from Republicans has been striking not just because defense secretaries are usually confirmed on a simple up-or-down vote, but also because Mr. Hagel, a Republican, served with many of them in the Senate until 2008.

“Senator Hagel’s performance at his confirmation hearing was deeply concerning, leading to serious doubts about his basic competence to meet the substantial demands of the office,” they said.

Senate Republicans narrowly blocked a vote on Mr. Hagel’s confirmation last week in a filibuster, forcing Democrats to put the matter off until senators return from recess next week.

Republicans have been using the filibuster to prevent final consideration of the nomination by refusing to end debate on it, a procedural step that requires 60 senators to vote in the affirmative.

But some Republicans, including Senator John McCain of Arizona, have since said that they will drop their objections. Mr. McCain was firm, saying on Sunday, “I don’t believe that we should hold up his nomination any further.”

Others, like Mr. Graham, Mr. Shelby and Ms. Fischer, have said that while they do not support a filibuster, they believe that the senators should have ample time to consider their votes, leaving themselves open to voting not to end debate next week.

Only one more Republican “yes” vote would be needed to cut off debate and carry through with a final vote if all the Republicans who voted to end the filibuster last week voted to do so again.

Because Mr. Hagel has the support of Senate Democrats, who control 55 seats, he is likely to clear a final vote.

If Senate Democrats move ahead with a vote and get the 60 votes necessary to end debate, Mr. Hagel could be confirmed as early as Tuesday. But because of procedural rules, any Republican could still delay the vote until Wednesday.

A new voice chimed in on the debate on Thursday. Bob Dole, the former Senate majority leader and, like Mr. Hagel, a decorated veteran, urged his fellow Republicans to put aside their objections.

“Hagel’s wisdom and courage make him uniquely qualified to be secretary of defense and lead the men and women of our armed forces,” Mr. Dole said, adding that he would be “an exceptional leader at an important time.”

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